Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions This data valid as documented CCRF for this category (Acetylenic geminalic diols)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement of GLP Compliance
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch: 21902
Purity: 99,15 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
Duration of exposure:
24 hours
Doses:
Dose level: 2000 mg/kg body weight
Dose Volume: 10 ml/kg body weight
No. of animals per sex per dose:
5 males and
5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no data on CL
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of ill health or behaioural changes were observed during study period.
Body weight:
Low body weight gain or body weight loss was noted in all animals over the first week of the study and improved weight gain over the second week.
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any significant abnormalities. Pelvic dilatation of the right kidney was noted in one males. Renal pelvic dilation is a common finding in animals of this age and strain and therefore considered not related to treatment.
Other findings:
Treated skin abnormalities:
Scales and scabs were observed on the treated skin area among two females between day 4 and 6.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The dermal LD50 value of Surfynol 104 in rats of either sex was established as exceeding 2000 mg/kg/ body weight.
Executive summary:

This study was entitle "Assessment of acute dermal toxicity with Surfynol 104 in the rat".

The purpose of this study was to assess the toxicity of Surfynol 104 when administered to rats asa a single dermal dose.

The study was carried out in accordance with OECD Guidline No. 402, "Acute Dermal Toxicity" and EEC Directive 92/96 /EEC, Part B.3, "Acute Toxicity - Dermal". Surfynol 104 was adminestered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the experimental period.

No mortality and no clinical signs of ill health were observed during the study. Skin abnormalities on the treated area included scales and scabs in two females between days 4 and 6. Low body weight gain or body weight loss was noted in all animals over the first week of the study and improved body weight gain over the second week. Macroscopic post mortem examination of the animals at termination did not reveal any significant abnormalities.

The dermal LD50 value of Surfynol 104 in rats of either sex was established as exceeding 2000 mg/kg/ body weight.

Based on these results and according to the EEC criteria for classification and labeling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Directive 67/548/EEC). Surfynol 104 cannot be classified and has no obligatory labeling reqiurement.